```

[Federal Register Volume 77, Number 184 (Friday, September 21, 2012)]
[Notices]
[Pages 58558-58560]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-23365]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier CMS-2567, CMS-10425, CMS-10417, CMS-10428, CMS-
1500 (02/12), and CMS-1500 (08/05)]

Agency Information Collection Activities: Submission for OMB 
Review; Comment Request

AGENCY: Centers for Medicare & Medicaid Services, HHS.

    In compliance with the requirement of section 3506(c)(2)(A) of the 
Paperwork Reduction Act of 1995, the Centers for Medicare & Medicaid 
Services (CMS), Department of Health and Human Services, is publishing 
the following summary of proposed collections for public comment. 
Interested persons are invited to send comments regarding this burden 
estimate or any other aspect of this collection of information, 
including any of the following subjects: (1) The necessity and utility 
of the proposed information collection for the proper performance of 
the Agency's function; (2) the accuracy of the estimated burden; (3) 
ways to enhance the quality, utility, and clarity of the information to 
be collected; and (4) the use of automated collection techniques or 
other forms of information technology to minimize the information 
collection burden.
    1. Type of Information Collection Request: Extension without change 
of a currently approved collection. Title of Information Collection: 
Deficiencies and Plan of Correction (CMS-2567) and Supporting 
Regulations contained in 42 CFR 488.18, 488.26, and 488.28. Use: 
Section 1864(a) of the Social Security Act requires that the Secretary 
use state survey agencies to conduct surveys to determine whether 
health care facilities meet Medicare and Clinical Laboratory 
Improvement Amendments participation requirements. The CMS-2567 form is 
the means by which the survey findings are documented. This section of 
the law further requires that compliance findings resulting from these 
surveys be made available to the public within 90 days of such surveys. 
The CMS-2567 form is the vehicle for this disclosure. The regulations 
at 42 CFR 488.18 require that state survey agencies document all 
deficiency findings on a statement of deficiencies and plan of 
correction, which is the CMS-2567. 42 CFR 488.26 and 488.28 further 
delineate how compliance findings must be recorded and that CMS 
prescribed forms must be used.
    The form is also used by health care facilities to document their 
plan of correction and by CMS, the states, facilities, purchasers, 
consumers, advocacy groups, and the public as a source of information 
about quality of care and facility compliance.
    Form Number: CMS-2567 (OCN 0938-0391). Frequency: Yearly and 
occasionally. Affected Public: Private Sector (Business or other for-
profit and not-for-profit institutions). Number of Respondents: 62,000. 
Total Annual Responses: 62,000. Total Annual Hours: 134,540. (For 
policy questions regarding this collection contact Angela Mason-Elbert 
at 410-786-8279. For all other issues call 410-786-1326.)
    2. Type of Information Collection Request: New collection; Title of 
Information Collection: Evaluation of Patient Satisfaction and 
Experience of Care for Medicare Beneficiaries with End-Stage Renal 
Disease (ESRD): Impact of the ESRD Prospective Payment System (PPS) and 
ESRD Quality Incentive Program (QIP) ; Use: The Medicare Prescription 
Drug Improvement, and Modernization Act of 2003 (MMA) required the 
Secretary of Health and Human Services (HHS) to submit to Congress a 
report detailing the elements and features for the design and 
implementation of a bundled End-Stage Renal Disease Prospective Payment 
System, specifying that such a system should include the bundling of 
separately billed drugs, clinical laboratory tests, and other items 
``to maximum extent feasible''. The Medicare Improvements for Patients 
and Providers Act of 2008 (MIPPA) directed the Secretary of HHS to 
implement a payment system under which a single payment is made to a 
provider of services or a renal dialysis facility for renal dialysis 
services in lieu of any other payment. The ESRD PPS combines composite 
rate dialysis services with separately billable services under a single 
payment adjusted to reflect patient differences in resource needs or 
case-mix. The MIPPA also stipulated the development of quality 
incentives for the ESRD program. CMS has established the End-Stage 
Renal Disease Quality Incentive Program (ESRD QIP) to address this 
provision of the legislation.
    In order to assess the impact of the final rule (76 FR 627) on ESRD 
beneficiary experiences, satisfaction, and health outcomes, CMS is 
requesting OMB approval to obtain input on the effect of the final rule 
on our ESRD beneficiaries. The purpose of this data collection effort 
is to assess beneficiary satisfaction and experience of care in terms 
of access to services, quality of care, outcomes, and cost. This will 
be measured through telephone surveys with ESRD beneficiaries and 
through interviews with key stakeholders in the renal health care 
community. The information obtained from both the beneficiary 
respondents and key stakeholders will be used to provide an initial 
reporting of the ESRD PPS/QIP's effects on beneficiary satisfaction and 
experience of care and to inform the Centers for Medicare & Medicaid 
Services (CMS) of the impact of the ESRD PPS/QIP on patient 
satisfaction and experience of care, including unintended consequences, 
for consideration of future modification of the programs.
    Subsequent to the publication of the 60-day Federal Register notice 
(77 FR 27777), the annual burden hours have decreased from 1,287 to 
662. Early cognitive interview findings of the ESRD Beneficiary Survey 
submitted during the 60 day notice exhibited respondent complaints that 
the survey was too long and some participants had to hang up early 
because they were feeling sick. Medicare beneficiaries with end stage 
renal disease (ESRD) are very sick and unable to remain cognitively 
aware for 30 minutes. The ESRD Beneficiary Survey was significantly 
shortened so that the time necessary to interview a single participant 
was reduced from 30 to 15 minutes. Form Number: CMS-10425 (OCN: 0938-
New); Frequency: Yearly; Affected

[[Page 58559]]

Public: Individuals. Number of Respondents: 2,540. Number of Responses: 
2,540. Total Annual Hours: 662. (For policy questions regarding this 
collection contact Steve Blackwell at 410-786-6852. For all other 
issues call 410-786-1326.)
    3. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Medicare Fee-for-
Service Prepayment Medical Review; Use: The information required under 
this collection is requested by Medicare contractors to determine 
proper payment or if there is a suspicion of fraud. Medicare 
contractors request the information from providers or suppliers 
submitting claims for payment from the Medicare program when data 
analysis indicates aberrant billing patterns or other information which 
may present a vulnerability to the Medicare program. In addition, we 
are specifically soliciting public comments on the information 
collection burden that is associated with the currently approved 
information collection request. Form Number: CMS-10417 (OMB 0938-0969); 
Frequency: Occasionally; Affected Public: Private Sector (Business or 
other for-profit and Not-for-profit institutions); Number of 
Respondents: 2,220,434; Total Annual Responses: 2,220,434; Total Annual 
Hours: 1,105,560. (For policy questions regarding this collection 
contact Debbie Skinner at 410-786-7480. For all other issues call 410-
786-1326.)
    4. Type of Information Collection Request: Extension of a currently 
approved collection; Title: Pre-Existing Condition Insurance Plan 
(PCIP) Authorization to Share Personal Health Information; Use: On 
March 23, 2010, the President signed into law H.R. 3590, the Patient 
Protection and Affordable Care Act (Affordable Care Act), Public Law 
111-148. Section 1101 of the law establishes a ``temporary high risk 
health insurance pool program'' (which has been named the Pre-Existing 
Condition Insurance Plan, or PCIP) to provide health insurance coverage 
to currently uninsured individuals with pre-existing conditions. The 
law authorizes HHS to carry out the program directly or through 
contracts with states or private, non-profit entities.
    Reapproval of this package is being requested as a result of CMS, 
in its administration of the PCIP program, serving as a covered entity 
under the Health Insurance Portability and Accountability Act (HIPAA). 
Without a valid authorization, the PCIP program is unable to disclose 
information, with respect to an applicant or enrollee, about the status 
of an application, enrollment, premium billing or claim, to individuals 
of the applicant's or enrollee's choosing. The HIPAA Authorization Form 
has been modeled after CMS' Medicare HIPAA Authorization Form (OMB 
control number 0938-0930) and is used by applicants or enrollees to 
designate someone else to communicate with PCIP about their protected 
health information (PHI).
    Unless permitted or required by law, the Health Insurance 
Portability and Accountability Act (HIPAA) Privacy Rule (Sec.  164.508) 
prohibits CMS' PCIP program (a HIPAA covered entity) from disclosing an 
individual's protected health information without a valid 
authorization. In order to be valid, an authorization must include 
specified core elements and statements.
    CMS will make available to PCIP applicants and enrollees a 
standard, valid authorization to enable beneficiaries to communicate 
with PCIP about their personal health information. This is a critical 
tool because the population the PCIP program serves is comprised of 
individuals with pre-existing conditions who may be incapacitated and 
need an advocate to help them apply for or receive benefits from the 
program. This standard authorization will simplify the process of 
requesting information disclosure for beneficiaries and minimize the 
response time for the PCIP program.
    Each individual will be asked to complete the form which will 
include providing the individual's name, PCIP account number (if 
known), date of birth, what personal health information they agree to 
share, the length of time the individual agrees their personal health 
information can be shared, the names and addresses of the third party 
the individual wants PCIP to share their personal health information 
with, and an attestation that the individual is giving PCIP permission 
to share their personal health information with the third party listed 
in the form. This completed form will be submitted to the PCIP benefits 
administrator, GEHA, which contracts with CMS.
    We estimate that it will take approximately 15 minutes per 
applicant to complete and submit a HIPAA Authorization Form to the PCIP 
program.
    The federally-run PCIP program operates in 23 states plus the 
District of Columbia and receives an average of 35,000 enrollment 
applications per year. To estimate the number of PCIP applicants and 
enrollees who may complete an authorization, we looked at the 
percentage of individuals who request an authorization in Medicare as a 
baseline. Medicare estimates 3% of its population will submit an 
authorization per year. However, since the PCIP program caters to an 
exclusive population comprised of individuals who have one or more pre-
existing conditions, we believe it is likely we could receive double 
the percentage estimated by Medicare. Accordingly, PCIP estimates 6% 
(or 2,100) of its applicants and enrollees may submit an authorization 
per year.
    It is estimated that up to 2,100 applicants and enrollees may 
submit an authorization annually. There is no cost to PCIP 
beneficiaries to request, complete, submit, or have the authorization 
form processed by PCIP. It should take approximately 15 minutes for a 
beneficiary to complete the authorization form. 15 minutes multiplied 
by 2,100 beneficiaries equals 525 hours. Form Number: CMS-10428 
(OCN: 0938-1161); Frequency: Reporting--Once; Affected Public: 
individuals or households; Number of Respondents: 2,100; Total Annual 
Responses: 2,100; Total Annual Hours: 525. (For policy questions 
regarding this collection contact Laura Dash at 410-786-8623. For all 
other issues call 410-786-1326.)
    5. Type of Information Collection Request: New collection; Title of 
Information Collection: Health Insurance Common Claims Form and 
Supporting Regulations at 42 CFR Part 424, Subpart C; Use: The Form 
CMS-1500 answers the needs of many health insurers. It is the basic 
form prescribed by CMS for the Medicare program for claims from 
physicians and suppliers. The Medicaid State Agencies, CHAMPUS/TriCare, 
Blue Cross/Blue Shield Plans, the Federal Employees Health Benefit 
Plan, and several private health plans also use it; it is the de facto 
standard ``professional'' claim form.
    Medicare carriers use the data collected on the CMS-1500 and the 
CMS-1490S to determine the proper amount of reimbursement for Part B 
medical and other health services (as listed in section 1861(s) of the 
Social Security Act) provided by physicians and suppliers to 
beneficiaries. The CMS-1500 is submitted by physicians/suppliers for 
all Part B Medicare. Serving as a common claim form, the CMS-1500 can 
be used by other third-party payers (commercial and nonprofit health 
insurers) and other federal programs (e.g., CHAMPUS/TriCare, Railroad 
Retirement Board (RRB), and Medicaid).
    However, as the CMS-1500 displays data items required for other 
third-party payers in addition to Medicare, the form is considered too 
complex for use by

[[Page 58560]]

beneficiaries when they file their own claims. Therefore, the CMS-1490S 
(Patient's Request for Medicare Payment) was explicitly developed for 
easy use by beneficiaries who file their own claims. The form can be 
obtained from any Social Security office or Medicare carrier.
    Most recently, the National Uniform Claim Committee (NUCC) has 
revised the CMS-1500. The NUCC began revision work on the 1500 Claim 
Form, version 02/12 in 2009. The goal of this work was to align the 
paper form with some of the changes in the electronic Health Care 
Claim: Professional (837), 005010X222 Technical Report Type 3 (5010) 
and 005010X222A1 Technical Report Type 3 (5010A1). During the revision 
work, consideration was given to different approaches to revising the 
form. The NUCC decided to proceed with making ``minor changes'' to the 
current form, which was defined as no physical changes to the existing 
form lines or underlying layout of the form. Once the CMS-1500 (02/12) 
has been approved, the CMS-1500 (08/05) will be discontinued after a 
form runoff period during which both the CMS-1500 (08/05) and the CMS-
1500 (02/12) can be used. Form Number: CMS-1500(02/12), CMS-1490-S 
(OMB: 0938-New); Frequency: Reporting--On occasion; Affected 
Public: State, Local, or Tribal Government, Business or other-for-
profit, Not-for-profit institutions; Number of Respondents: 1,448,346; 
Total Annual Responses: 988,005,045; Total Annual Hours: 21,418,336. 
(For policy questions regarding this collection contact Claudette 
Sikora at 410-786-5618. For all other issues call 410-786-1326.)
    6. Type of Information Collection Request: Reinstatement without 
change of a previously approved collection; Title of Information 
Collection: Health Insurance Common Claims Form and Supporting 
Regulations at 42 CFR Part 424, Subpart C; Form Number: CMS-1500(08/
05), CMS-1490-S (OMB: 0938-0999); Use: The Form CMS-1500 
answers the needs of many health insurers. It is the basic form 
prescribed by CMS for the Medicare program for claims from physicians 
and suppliers. The Medicaid State Agencies, CHAMPUS/TriCare, Blue 
Cross/Blue Shield Plans, the Federal Employees Health Benefit Plan, and 
several private health plans also use it; it is the de facto standard 
``professional'' claim form.
    Medicare carriers use the data collected on the CMS-1500 and the 
CMS-1490S to determine the proper amount of reimbursement for Part B 
medical and other health services (as listed in section 1861(s) of the 
Social Security Act) provided by physicians and suppliers to 
beneficiaries. The CMS-1500 is submitted by physicians/suppliers for 
all Part B Medicare. Serving as a common claim form, the CMS-1500 can 
be used by other third-party payers (commercial and nonprofit health 
insurers) and other Federal programs (e.g., CHAMPUS/TriCare, Railroad 
Retirement Board (RRB), and Medicaid).
    However, as the CMS-1500 displays data items required for other 
third-party payers in addition to Medicare, the form is considered too 
complex for use by beneficiaries when they file their own claims. 
Therefore, the CMS-1490S (Patient's Request for Medicare Payment) was 
explicitly developed for easy use by beneficiaries who file their own 
claims. The form can be obtained from any Social Security office or 
Medicare carrier. Frequency: Reporting--On occasion; Affected Public: 
State, Local, or Tribal Government, Business or other-for-profit, Not-
for-profit institutions; Number of Respondents: 1,448,346; Total Annual 
Responses: 988,005,045; Total Annual Hours: 21,418,336. (For policy 
questions regarding this collection contact Claudette Sikora at 410-
786-5618. For all other issues call 410-786-1326.)
    To obtain copies of the supporting statement and any related forms 
for the proposed paperwork collections referenced above, access CMS Web 
site address at http://www.cms.hhs.gov/PaperworkReductionActof1995, or 
Email your request, including your address, phone number, OMB number, 
and CMS document identifier, to Paperwork@cms.hhs.gov, or call the 
Reports Clearance Office on (410) 786-1326.
    To be assured consideration, comments and recommendations for the 
proposed information collections must be received by the OMB desk 
officer at the address below, no later than 5 p.m. on October 22, 2012. 
OMB, Office of Information and Regulatory Affairs, Attention: CMS Desk 
Officer, Fax Number: (202) 395-6974, Email: OIRA_submission@omb.eop.gov.

    Dated: September 18, 2012.
Martique Jones,
Director, Regulations Development Group, Division B, Office of 
Strategic Operations and Regulatory Affairs.
[FR Doc. 2012-23365 Filed 9-20-12; 8:45 am]
BILLING CODE 4120-01-P
```